Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

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Mission-Driven Professionals And Students Build America's Supply Chains

Tales of purpose-led careers that bring innovations to business leaders and opportunities to university students. They inspire us. Chief Editor Louis Garguilo documents two such professionals who have combined to help domestic manufacturing organizations locate each other and power their operations, and to get students involved in the industry.

GUEST COLUMNISTS

Are Biopharma Companies Outsourcing Their Ability To Think?
Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.
June 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.
Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts
Version-controlled quality target product profiles, authored by the drug sponsor, close any gaps between the CDMO's and sponsor's definitions of quality.
Reshoring Pressure Meets Manufacturing Reality
U.S. pharma can't reshore what domestic capacity can't absorb. Senior leaders from Takeda, Biogen, Eli Lilly, and others reveal why tariff pressure is colliding with a sterile fill-finish shortage, workforce gaps, and ADC capacity bottlenecks.
CDMO Live Europe 2026: Partnerships For An Uncertain World
112 pages of executive insight from CDMO Live Europe 2026: tariffs, geopolitics, supply resilience, AI in manufacturing, and why strategic partnerships remain aspirational for most.
Resilience, Risk, And Relationships: CDMO Live Europe 2026 Report
Senior pharma leaders from Pfizer, Bayer, BioNTech and others debunk dual sourcing myths and reveal what separates strategic CDMO partnerships from transactional ones.
Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring
Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.

PHARMA OUTSOURCING WHITE PAPERS

Filling Gaps In Drug Discovery Pipelines: From Candidate To Clinic
See how existing partnerships with NIH allowed the chance to bring together government, academic, and industry resources through strategic initiatives that streamline processes and maximize benefits.

Drug Substance For Early Clinical Phase Initiation
Explore how proactive nitrosamine impurity risk assessment protects early clinical drug supply, minimizes development delays, and enables confident progression to first‑in‑human studies.
Open-Label Study Assessing Relative And Absolute Bioavailability
Consistent absorption across different formulations and dietary conditions ensures stable therapeutic exposure. This flexibility simplifies patient dosing schedules and supports manufacturing transitions.
Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products
Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.
Mammalian Cell Line Development
Explores how modern cell line engineering boosts speed, stability, and scalability across biologics, with practical insights to cut risk and improve readiness for downstream development.
Optimizing Safety Measures For rAAV Therapies
Explore common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.